Section 4731-35-02 - Standards for managing drug therapy(A) A practitioner may elect to manage the drug therapy of an established patient by entering into a consult agreement with a pharmacist. The agreement is subject, but not limited to, the following standards: (1) The primary practitioner must ensure that the managing pharmacist has access to the patient's medical record, the medical record is accurate, and that while transferring the medical record, the primary practitioner ensures the confidentiality of the medical record.(2) The practitioner must have an ongoing practitioner-patient relationship with the patient whose drug therapy is being managed, including an initial assessment and diagnosis by the practitioner prior to the commencement of the consult agreement.(3) With the exception of inpatient management of patient care at an institutional facility as defined in agency 4729 of the Administrative Code, the practitioner, prior to a pharmacist managing the patient's drug therapy, shall communicate the content of the proposed consult agreement to each patient whose drug therapy is managed under the agreement, in such a manner that the patient or the patient's representative understands scope and role of the managing pharmacist, which includes the following: (a) That a pharmacist may be utilized in the management of the patient's care;(b) That the patient or an individual authorized to act on behalf of a patient has the right to elect to participate in and to withdraw from the consult agreement.(c) Consent may be obtained as part of the patient's initial consent to treatment.(4) The diagnosis by the practitioner must be within the practitioner's scope of practice.(5) The practitioner shall meet the minimal and prevailing standards of care.(6) The practitioner must ensure that the pharmacist managing the patient's drug therapy has the requisite training, and experience related to the particular diagnosis for which the drug therapy is prescribed. Practitioners practicing at institutional or ambulatory outpatient facilities may meet this requirement through institutional credentialing standards or policies.(7) The practitioner shall review the records of all services provided to the patient under the consult agreement.(B) Quality assurance mechanisms. The following quality assurance mechanisms shall be implemented to verify information contained within the consult agreement, and ensure the managing pharmacist's actions are authorized and meet the standards listed in paragraphs (A) and (B) of this rule:(1) Verification of ongoing practitioner-patient relationship. A practitioner-patient relationship can be established by detailing criteria set forth in paragraph (A)(2) of this rule, within the consult agreement.(2) Verification that practitioner diagnosis is within the practitioner's scope of practice. Establishing that a diagnosis is within the practitioner's scope of practice may be established by detailing the criteria set forth in paragraph (A)(4) of this rule, within the consult agreement.(3) Verification that pharmacist's training and experience is related to the drug therapy. Establishing that a pharmacist's requisite training and experience with a particular drug therapy is related to the diagnosis for which the drug therapy is prescribed, may be established by detailing the criteria set forth in paragraph (A)(6) of this rule, within the consult agreement.(C) Continuous quality improvement program. The following should be included in the development of a continuous quality improvement program in order to evaluate the effectiveness of patient care and ensure positive patient outcomes:(1) Notifications to primary practitioner. The managing pharmacist must notify the primary practitioner of the following situations regarding any pharmacist authorized to manage drug therapy under the agreement: (a) A pharmacist has had their pharmacist license revoked, suspended, or denied by the state board of pharmacy;(b) If prescribing controlled substances, a pharmacist has failed to renew their controlled substance prescriber registration;(c) If prescribing controlled substances, a pharmacist fails to obtain or maintain a valid D.E.A. registration;(D) Overriding decisions of managing pharmacist. Any authorized practitioner identified under the consult agreement may override any decision, change, modification, evaluation or other action by any pharmacist acting pursuant to consult agreement or under the direction of the managing pharmacist, that was made with respect to the management of the patient's drug therapy under the consult agreement.Ohio Admin. Code 4731-35-02
Effective: 12/31/2021
Five Year Review (FYR) Dates: 10/31/2025
Promulgated Under: 119.03
Statutory Authority: 4729.39, 4731.05
Rule Amplifies: 4729.39
Prior Effective Dates: 10/31/2020